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CTRI Number  CTRI/2025/04/085914 [Registered on: 29/04/2025] Trial Registered Prospectively
Last Modified On: 25/04/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia
Dentistry 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Comparing Different Treatments to Heal Bone Loss Caused by Severe Gum Disease Using Laser Therapy, Natural Proteins, and Growth Factors 
Scientific Title of Study   CLINICAL AND RADIOGRAPHICAL EVALUATION OF PHOTOBIOMODULATION WITH ENAMEL MATRIX DERIVATIVE (EMD) AND CONCENTRATED GROWTH FACTOR (CGF) IN THE MANAGEMENT OF INTRABONY PERIODONTAL DEFECTS IN STAGE III or IV PERIODONTITIS PATIENTS: A MULTI ARM PARALLEL GROUP RANDOMIZED TRIAL 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  SIVSRI ROSHAN G M 
Designation  Post graduate student 
Affiliation  SRM Dental College Ramapuram 
Address  Department of peridontology, SRM Dental College, Bharathi Salai, Ramapuram, Chennai.

Chennai
TAMIL NADU
600089
India 
Phone  7010561672  
Fax    
Email  sivsri10474@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DR DHAYANAND JOHN VICTOR 
Designation  HOD, Professor of Department of Periodontics 
Affiliation  SRM Dental College Ramapuram 
Address  Department of peridontology, SRM Dental College, Bharathi Salai, Ramapuram, Chennai.

Chennai
TAMIL NADU
600089
India 
Phone  9841009952  
Fax    
Email  dr.djvictor@gmail.com  
 
Details of Contact Person
Public Query  
Name  DHAYANAND JOHN VICTOR 
Designation  HOD, Professor of Department of Periodontics 
Affiliation  SRM Dental College Ramapuram 
Address  Department of peridontology, SRM Dental College, Bharathi Salai, Ramapuram, Chennai.

Chennai
TAMIL NADU
600089
India 
Phone  9841009952  
Fax    
Email  dr.djvictor@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  SIVSRI ROSHAN G M 
Address  1st Year MDS Student, Department of periodontics, SRM Dental College, Bharathi Salai, Ramapuram, Chennai-89. 
Type of Sponsor  Other [Self funded] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DR SIVSRI ROSHAN G M  SRM Dental College Ramapuram  Department of Periodontics, SRM Dental College, Bharathi Salai, Ramapuram, Chennai-89.
Chennai
TAMIL NADU 		 7010561672

sivsri1074@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL REVIEW BOARD  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K053||Chronic periodontitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Periodontal Regeneration in Intrabony defects using Photobimodulation  15 sites with 2 or 3 walled defects in Stage III or IV Periodontal Diseases treated with open flap debridement and photobiomodulation  
Intervention  Periodontal Regeneration in Intrabony defects using Photobimodulation and Emdogain  15 sites with 2 or 3 walled defects in Stage III or IV Periodontal Diseases treated with open flap debridement and photobiomodulation and Emdogain 
Intervention  Periodontal Regeneration in Intrabony defects using Photobimodulation, Emdogain and Concentrated Growth Factor   15 sites with 2 or 3 walled defects in Stage III or IV Periodontal Diseases treated with open flap debridement and photobiomodulation, Emdogain and Concentrated Growth Factor 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients with an age range of 18 to 60.
Patients with probing pocket depth greater than or equal to 6 mm and clinical attachment loss of greater than or equal to 3 mm.
Patients with 2 walled or 3 walled intrabony defects, with a defect depth of greater than or equal to 3 mm.
Full-mouth plaque score (FMPS) less than 20 percent after phase I therapy
Full-mouth bleeding score(FMBS) less than 20 percent after phase I therapy
Systemically healthy patients; with no disease that will have a bearing on the outcome of the surgical intervention
 
 
ExclusionCriteria 
Details  Patients diagnosed with mal-alignment at the defect site
Patients with systemic disease or drugs that contraindicate periodontal surgery.
Patients with a history of smoking and pan chewing.
Sites with advanced furcation involvement.
Pregnant and lactating women 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To evaluate and compare the following clinical outcome measures:
1.Clinical Attachment Level gain (CAL) between groups.
2.Probing Pocket Depth (PPD) reduction between groups.
3.Radiographic bone fill between the groups  		 Baseline
1 month
3 month
6 month
12 month 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate and compare the position of the gingival crest between the groups.  Baseline
1 month
3 month
6 month
12 month 
 
Target Sample Size   Total Sample Size="55"
Sample Size from India="55" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   28/05/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Regenerative Management of Periodontal Intrabony Defects

Periodontal intrabony defects present a significant clinical challenge, often threatening tooth stability. Regenerative therapies aim to restore lost bone and supporting tissues, improving both function and aesthetics while preserving natural dentition.

Photobiomodulation (PBM) at 650 nm offers a non-invasive adjunctive treatment that promotes periodontal regeneration. It enhances fibroblast activity, collagen synthesis, angiogenesis, and growth factor production, while also reducing inflammation. These effects accelerate healing and improve clinical outcomes, including attachment gain and probing depth reduction.

Enamel Matrix Derivative (EMD), derived from developing enamel, stimulates the proliferation and differentiation of cells critical for periodontal regeneration. EMD promotes cementum and periodontal ligament formation, enhances angiogenesis, modulates inflammation, and supports new bone growth, leading to improved clinical attachment and radiographic bone fill.

Concentrated Growth Factor (CGF), an autologous platelet-rich plasma derivative, is rich in growth factors that promote cell proliferation and differentiation. CGF enhances wound healing through angiogenesis and inflammation reduction, contributing to effective bone and tissue regeneration.

Combining PBM, EMD, and CGF may provide a synergistic effect, amplifying individual benefits. PBM improves healing dynamics and growth factor activity, EMD stimulates tissue regeneration, and CGF accelerates repair. Together, they may significantly enhance the regenerative response in intrabony defects, offering a superior alternative to conventional therapies with improved long-term outcomes.

 
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